October 2017

Researchers to use Climate Data to Better Predict Marine Distribution in Northeast

Scientists from Stony Brook University’s School of Marine and Atmospheric Sciences (SoMAS) will be developing seasonal predictions of fish and marine mammal distributions in the Northeast United States with the goal to enhance protected species management. The research is supported by a $509,573 grant from the National Oceanic and Atmospheric Administration’s (NOAA) National Marine Fisheries Service Office of Science and Technology, in partnership withNOAA Research’s Modeling, Analysis, Predictions, and Projections (MAPP) Program.

From left, Hyemi Kim, Janet Nye and Lesley Thorne

The Northeast U.S. large marine ecosystem is highly productive and supports important commercial and recreational fisheries. It has also experienced some of the highest warming rates in recent decades. Communities in the Northeast have observed many climate-driven changes including shifts in fish distribution for most fish species, as well as changes in the timing of breeding or spawning, seasonal movements, and migrations.

Given these changes, the SoMAS team will use climate information to predict fish and marine mammal distributions on seasonal timescales to help fishermen and decision makers adjust their management approaches based on environmental conditions.

The team also plans to experiment with using these predictions to help reduce the incidental capture of non-target species, known as bycatch. Bycatch can increase costs and decrease yield for commercial fisherman, but more precise seasonal predictions of where marine mammals and fish will be distributed could decrease the likelihood of this concern.

“While traditional management approaches have focused on fixed areas, it is becoming increasingly recognized that bycatch could be reduced by incorporating dynamic environmental variables such as temperature into models to estimate high risk areas for fisheries bycatch,” said Lesley Thorne, PhD, Assistant Professor in SoMAS and lead investigator of the project, titled “Probabilistic Seasonal Prediction of the Distribution of Fish and Marine Mammals in the Northeast U.S.”

By combining species distribution models with climate models, the team will help predict where marine mammals and non-target species are most likely to occur over the next season.

“This information could have a significant impact in reducing fisheries bycatch,” said Thorne.

As part of this project, the research team will participate in the NOAA MAPP Program’s new Marine Prediction Task Force. The Task Force will allow the researchers to collaborate with other MAPP-funded scientists working on related projects, and combine resources and expertise to rapidly advance project objectives.

Co-investigators for the project are Hyemi Kim, PhD, and Janet Nye, PhD, both Assistant Professors in SoMAS.

Saltz Leads Cancer Imaging Pathology Effort with Collaborative $8M Grant

The National Cancer Institute (NCI) has awarded Joel Saltz, MD, together with and a team of researchers from the University of Arkansas and Emory University, a $8M grant over the next five years to develop an integrated Radiology/Pathology/”omics” data repository that will enable team science research with the ultimate goal of developing ways of steering cancer treatment. This effort will develop and deploy tools to create large collections of well-curated data for algorithm testing and validation.

Cherith Chair of Biomedical Informatics Joel Saltz

“Cancer is a complex multifactorial disease state and the ability to anticipate and steer treatment results will require information synthesis across multiple scales from the host to the molecular level,” said Dr. Saltz, vice president for clinical informatics and founder and Cherith chair of the Department of Biomedical Informatics, which is jointly administered by the College of Engineering and Applied Sciences and the School of Medicine,  at Stony Brook University.

Dr. Saltz, who is also an associate director of the Stony Brook Cancer Center, is one of a team  of PIs on the project, and is leading the Pathology component .  This effort leverages Dr. Saltz other NCI funded efforts including the NCI project: “Tools to Analyze Morphology and Spatially Mapped Molecular Data ”.  Dr. Saltz is a pioneer in the biomedical informatics field, which uses computational methods to extract meaning from large data sets. H is ground-breaking work in digital image archiving systems for pathology images has led to the FDA’s approval of using digital surgical pathology slides for interpretations.

“Joel’s work and leadership of the Department of Biomedical Informatics is a tremendous example of the interdisciplinary research underway between engineering and medicine at Stony Brook University,” said Fotis Sotiropoulos, Dean of the College of Engineering and Applied Sciences . “We look forward to supporting Joel over the next five years, and the innovation his team will contribute to tracking and fighting cancer.”

Dr. Saltz founded and built two highly successful departments of biomedical informatics, one at Ohio State University and one at Emory University.  In 2013, he joined Stony Brook as Vice President for Clinical Informatics and Founding Department Chair of Biomedical Informatics – to create a living laboratory for biomedical informatics and to create a third unique biomedical informatics department dually housed in the Stony Brook School of Medicine and the College of Engineering and Applied Sciences.

BME Professor Receives NSF Funding to Advance Microfluidic Technology

Eric Brouzes, an assistant professor in the Department of Biomedical Engineering, has been awarded a grant from the National Science Foundation CBET division entitled, “Physical Principles of Magnetic Extraction from Microfluidic Droplets.” This three-year, $300K award will study the extraction of magnetic beads from microfluidic droplets with the translational goal of developing an efficient way to access genetic information of single cells at high speed.

These droplets are extremely stable, they act as capsules that do not merge with each other unless directed, and can be precisely controlled at high speed. That approach has proven beneficial in many applications, such as the study of the immune system or cancer, and has the potential to revolutionize many biomedical and chemical applications.

The missing capability of the droplet toolbox is the faculty to purify specific molecules from those reactors. Professor Brouzes will address a critical need to understand the fundamental physics phenomena that govern the behavior of those droplets in the presence a magnetic field to achieve this goal.

“In this technology, each droplet carries out a reaction and can then be manipulated at rates as high as several thousands of reactions per second,” said Brouzes. “This research will help increase the pace of discovery by enabling the miniaturization of most laboratory techniques using tiny droplets of water controlled at very high speed into networks of small conduits.”

“Professor Brouzes’ work on droplet microfluid technology exemplifies our progressive approach to engineering-driven medicine,” said Fotis Sotiropoulos, Dean of the College of Engineering and Applied Sciences. “I applaud this well-deserved recognition, and look forward to working with him over the next three years as his research in this important area progresses.”

Professor Brouzes joined the faculty of Stony Brook University’s College of Engineering and Applied Sciences in 2011. His research explores the advantages conferred by droplet microfluidics over conventional technologies and other microfluidics techniques in terms of automation, throughput and combinatorial power for the manipulation and analysis of single cells. With a team of students and researchers, Brouzes is combining droplet microfluidics and state-of-the-art molecular techniques like next-generation sequencing to conduct genomic profiling of tissues at single-cell resolution.

“This multidisciplinary approach will have a direct impact on the basic science of cancer and at the clinical level by improving the way cancer progression is assessed and monitored,” said Brouzes.

NIH R-Type Award Workshop Series, November 8th and November 15th

Please RSVP HERE by Monday, October 30th

The 'UH form' (Application for Approval to Conduct Research at Stony Brook University Hospital) has been updated

Along with the other folks with whom you must share your study and from whom you must obtain endorsement before starting it, there are two research activities that require additional action too:

  • If your research involves research-related radiation, you need to share and obtain endorsement from Sean Harling
  • If you use surgical pathology or cytology specimens, you need to share your study with James Davis and Jingxuan Liu (on behalf of the SBU Biobank). Note that you only need endorsement from Dr. Davis OR Dr. Liu to satisfy this requirement.

Reminder: the NIH Policy on the Use of a Single IRB (sIRB) for Multi-Site Research becomes effective January 25, 2018

So, what do you need to know?

1. The policy goes into effect for all grants (new, renewal, revision, or re-submission) going in to NIH for funding with an receipt date of January 25, 2018. Multi-site studies within ongoing, non-competing awards will not be expected to comply with the policy until a competing renewal application is submitted.

2. The policy covers all domestic (US) sites of NIH-funded, non-exempt, multi-site studies.

3. The policy applies only to studies where the same research protocol is being conducted at more than one site; it does not apply to studies that involve more than one site but the sites have different roles in carrying out the research.

4. Applicants for NIH funding will be expected to submit a plan in the grant identifying the sIRB that will serve as the IRB of record for all study sites. It will be the responsibility of the applicant to assure that the sIRB is qualified to serve; (the applicant’s plan will not be evaluated in peer review). Please contact our office early on if you are the one who will need to come up with that plan so that we can ensure an appropriate choice for IRB, given the study parameters etc.

5. IRBs that are chosen to review on behalf of multiple sites will (likely) start charging a fee for the review. The additional costs associated with sIRB review may be charged to grants or contracts. The Office of Sponsored Programs is gearing up to help you know what's allowed budget-wise and whether or not its direct or indirect costs etc.

6. There are exceptions to this requirement and they will be granted if the use of an sIRB is prohibited by federal, state, or tribal laws or regulations, and for other reasons that are not likely to apply to us too often.

This is the link to the details of the policy: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html (ignore the effective date of May 2017, it was changed to the January date).

Announcements from the NIH's Office of Science Policy

Stay up to date on announcements from the NIH Office of Science Policy here: https://osp.od.nih.gov/announcements/

Training Resources - NIH Clinical Trial Policies

Our federal friends have been very busy lately, on seemingly everything but finalizing that pesky new final 'Common Rule' regulation (yup, still no word). Since they (read as NIH) understand we have been inundated, NIH recently released these resources to help you understand the NIH clinical trial definition and the related policies that have been issued (note the webinar on October 18th on Single IRB requirement effective January 2018): https://grants.nih.gov/policy/clinical-trials/training-resources.htm

Wh​ere is Stony Brook's webpage for everything you need to know about conducting human research at SBU?

Right here: http://research.stonybrook.edu/human-subjects

and the Standard Operating Procedures are here: http://research.stonybrook.edu/human-subjects-standard-operating-procedures

You are (really, very) strongly urged to bookmark these pages!

Wh​at's going on with our AAHRPP accreditation?​

Thanks for asking. Our Step 1 application has been submitted and is being reviewed. Once tweaks are made, and our Step 2 is in, I will send you some of the more significant changes to our SOPs that you will need to know about, as well as more on our move from IRBNet to myResearch (Click).

NEW: NIH's Policy on Certificates of Confidentiality (CoC) has been revised

NEW: NIH's Policy on Certificates of Confidentiality (CoC) has been revised ​​

OK, this one became effective on 10/1/17 (Sunday) but actually applies to all research that commenced or was ongoing on or after December 13, 2016. ​

In a nutshell:

· CoCs are issued automatically when research is conducted or supported by NIH and falls within the scope of the NIH policy.

· Research that is not funded by NIH (non-NIH research) may still have the protections afforded by CoCs through successful application ​ (as before) to the NIH, FDA, or other authorized Federal agencies or departments. ​

When CoC's are issued (automatically or by application) the person(s) engaged in the research must not disclose or provide the name of a subject or any information, document, or biospecimen that contains identifiable, sensitive information about the subject and that was compiled for the purposes of the research:

1. In any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, unless the disclosure is made with the consent of the individual to whom the information, document, or biospecimen pertains; or

2. To any other person not connected with the research, unless:

          a. Required by Federal, State, or local laws (e.g., adverse event reporting to the FDA, transmissible disease reporting required under State law), but excluding proceedings as described in “1” above;

          b. Necessary for the medical treatment of the subject to whom the information, document, or biospecimen pertains and made with the consent of the subject;

          c. Made with the consent of the individual to whom the information, document, or biospecimens pertains; or

          d. Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

​But, what exactly is identifiable, sensitive, information? Those of you who have CoC's know that it USED to protect to information obtained from subjects that could get them in legal etc. trouble (drug use etc.). NOW, the definition is: ​"information that is about an individual and that is gathered or used during the course of biomedical, behavioral, clinical, or other research and

1. Through which an individual is identified; or

2. For which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.​"​​

​Yes, it's true. ​We are going to need some guidance from NIH on a lot of what I just told you, and we will keep you informed accordingly. Here's the notice of changes from NIH: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html​.

REMINDER: NIH-funded investigators and staff must be trained in GCP

This is an oldie that I sent to you before (effective date was 1/1/17), but it bears repeating:

All NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP).

Reminder as to NIH's definition: A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

The great news is that our CITI GCP course satisfies this requirement, with a refresher needed every 3 years.

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